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    DRUG:

    Yescarta (axicabtagene ciloleucel)

    i
    Other names: KTE-C19 CAR, anti-CD19 chimeric antigen receptor transduced T cells, KTEC19, KTE-C19, KTE-C19 chimeric antigen receptor T cell therapy, FKC876, FKC-876, anti-CD19-CAR PBL, anti-cluster of differentiation 19 (CD19)-CAR PBL, FKC 876
    Company:
    Cabaret Biotech, Fosun Kite, Gilead, National Cancer Institute
    Drug class:
    CD19-targeted CAR-T immunotherapy
    Related drugs:
    1d
    Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells (clinicaltrials.gov)
    P2, N=56, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Apr 2028 --> Jan 2029
    Enrollment open • Trial completion date • Trial primary completion date
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    BCL2 (B-cell CLL/lymphoma 2)
    |
    Yescarta (axicabtagene ciloleucel)
    3d
    Non-ICANS neurotoxicities CD19-directed CAR T-cell therapy and the emergence of movement and neurocognitive treatment-emergent adverse events: a case report. (PubMed, Front Immunol)
    We report a 63-year-old male patient with diffuse large B-cell lymphoma (DLBCL) who developed delayed-onset neurotoxicity on day +22 following CD19-directed CAR T-cell therapy with axicabtagene ciloleucel (axi-cel), after an initial episode of CRS and ICANS...Follow-up neuropsychological testing revealed persistent deficits in attention and processing speed. This case broadens the known neurotoxicity spectrum of CAR T-cell therapies and underscores the need for heightened clinical vigilance and refined diagnostic criteria beyond ICANS, even in CD19-targeted settings.
    Journal • Adverse events
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    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • NEFL (Neurofilament Light Chain)
    |
    Yescarta (axicabtagene ciloleucel)
    8d
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jan 2026 --> Jun 2026
    Trial primary completion date
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    8d
    Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=23, Terminated, Jonsson Comprehensive Cancer Center | Trial completion date: Jun 2027 --> Feb 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Feb 2026; slow accrual
    Trial completion date • Trial termination • Trial primary completion date
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV • Kineret (anakinra)
    18d
    ARIISE - ASCs in recently diagnosed non-ischemic heart failure (2025-520837-22-00)
    P1/2, N=90, Not yet recruiting, Cell2Cure ApS
    New P1/2 trial
    |
    Yescarta (axicabtagene ciloleucel)
    23d
    NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
    1m
    Case Report: CD19 CAR-T therapy induces durable remission in a pediatric patient with TP53-mutated, refractory Burkitt lymphoma: a 30-month follow-up. (PubMed, Front Oncol)
    This case, among the youngest reported uses of commercial Axi-cel for BL, highlights the diagnostic complexity in adolescent lymphoma and demonstrates that CD19 CAR-T therapy can overcome TP53-associated chemoresistance in adolescent BL. It also suggests that integrating molecular profiling and immunotherapy may provide new strategies for managing high-risk, treatment-refractory cases in the adolescent and young adult population.
    Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Yescarta (axicabtagene ciloleucel)
    1m
    ZUMA-24: Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=35, Completed, Kite, A Gilead Company | Active, not recruiting --> Completed
    Trial completion
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CSF2 (Colony stimulating factor 2) • IL15 (Interleukin 15) • IL1R1 (Interleukin 1 receptor, type I) • IL7 (Interleukin 7)
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV
    1m
    Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=396, Recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Dec 2025 --> Jun 2030
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    1m
    A single-arm, single-center, open-label clinical study on the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors (ChiCTR2600116310)
    P4, N=20, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New P4 trial
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    TP53 mutation
    |
    Yescarta (axicabtagene ciloleucel)
    1m
    Apheresis CD8+CCR7+CD45RA- T-Cells as a Novel Biomarker Associated with CAR T-Cell Kinetics and Clinical Outcome. (PubMed, Int J Mol Sci)
    In apheresis, a cut-off value of >4.3% of CD8+ TCM predicted strong CAR-T expansion (AUC: 0.80; p = 0.023) and superior progression-free survival (p = 0.04) compared with patients who had CD8+ TCM below the cut-off. Our data suggest that high frequencies of CD8+ TCM cells in apheresis samples may represent a promising pre-treatment biomarker associated with strong CAR-T expansion and superior clinical outcome in r/r LBCL patients following axi-cel.
    Clinical data • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD38 (CD38 Molecule) • CCR7 (Chemokine (C-C motif) receptor 7)
    |
    Yescarta (axicabtagene ciloleucel)
    2ms
    Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL (clinicaltrials.gov)
    P1/2, N=30, Suspended, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026 | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Sep 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    LDH elevation
    |
    cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Lymphir (denileukin diftitox-cxdl)